Thomas Stüdeli, PhD, Eur.Erg., is a leading Human Factors Engineering expert in the medical device and combination product industry. His significant experience at Roche and Merck showcases a consistent history of establishing effective HFE processes and guiding the development of user-centered, regulatory-compliant products. Dr. Stüdeli has a proven ability to build and lead high-performing teams, navigate complex regulations, apply user-centered design, and implement robust risk management strategies. He actively shapes international standards for medical device usability and risk management (including IEC 62366 and ISO 14971) through his participation in the Technical Committee 62 of IEC (Medical Devices) and the Joint Working Group 4 (JWG4) of IEC/ISO (Usability of Medical Devices). His core expertise spans user-centered design, risk management, regulatory intelligence, ergonomics, and industrial design. As a Principal Human Factors Engineer and Device Team Leader at Roche, Dr. Stüdeli leverages his deep understanding of human factors to drive successful product development. His contributions to the field are further demonstrated through his extensive academic publications and invited presentations.